The clock is ticking for medical device manufacturers operating in the European Union as we move tow...
Life Sciences Blog
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In the pharmaceutical industry, a Quality Management System (QMS) is the backbone of your compliance...
If you are a manufacturer of medical devices or in vitro diagnostic (IVD) devices based outside Swit...
For medical device and in vitro diagnostic (IVD) manufacturers located outside the United Kingdom, a...
For medical and in vitro diagnostic device manufacturers based outside the European Union, accessing...
Under the EU Medical Device Regulation (MDR), usability is no longer a ‘nice-to-have’—it’s a core co...
In-silico testing — using computational modeling and simulation techniques — has rapidly become an i...
Medical Device Software (MDSW) development can feel like a regulatory labyrinth, especially for star...
In the ever‑evolving life sciences industry, digitization is no longer optional — it’s a strategic i...
For medical device startups, market access and investor trust hinge on a robust Quality Management S...
Cybersecurity has become a fundamental requirement under the Medical Device Regulation (MDR). Medica...
A Laboratory Information Management System (LIMS) is more than just software; it’s the operational b...
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Post-Market Clinical Follow-up (PMCF) is no longer optional. Under the EU Medical Device Regulation ...
Since the Medical Device Regulation (MDR) 2017/745 came into full effect on May 26, 2021, post-marke...
As of February 2, 2025, Article 4 of the EU AI Act is in force. This means AI providers and deployer...
In regulated environments such as pharmaceutical manufacturing, laboratory research, and clinical tr...
In clinical research, the success of a trial heavily depends on two key factors: recruiting enough e...
Effective site selection and qualification are the cornerstones of any successful clinical trial. By...
Picture this: you’re racing to get a promising new therapy from lab bench to patient bedside, only t...
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With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical d...
With rapid advancements in medical technology reshaping healthcare, new devices and innovations are ...
In the pharmaceutical and medical device industries, maintaining compliance with regulatory standard...
The life sciences landscape is vast, complex, and rapidly changing, so it can be hard to navigate. V...
Scientists outside of science Many scientists catch the research bug as children. For some, the inci...
So, you’ve made a huge breakthrough on a project you’ve been working on forever, or found that your ...
In a previous blog post, we talked about the various activities that take place during an inspection...
Getting monetary value out of all your R&D efforts is key to the long-term success of your busin...
In a previous blog post “Regulatory Inspection Readiness: A Proactive Approach to CAPA and Complianc...
“Send” – After weeks of collaboration with the operations team, legal advisors, and experts, a detai...
On January 31, 2024, the US Food and Drug Administration (FDA) published its long-anticipated final ...
With the Medical Device Regulation (MDR 2017/745) being more stringent than the previous European Me...
The AI Act was formally adopted by the full European Parliament on 13 March, and we have reviewed th...
In earlier blog posts, we spotlighted the EU member states – Germany, Belgium, and France – and thei...
U.S. Basic Requirements for DTx Products Subject to the U.S. Health Authority (FDA) regulations, spe...
Digital therapeutics (DTx) represent an exciting frontier in healthcare, leveraging clinically valid...
Medical Devices CE certified under the European Medical Device Directive (MDD) or the Active Implant...
Germany has always been renowned for its meticulous attention to detail, often described by the term...
All Digital Therapeutics (DTx) must adhere to the EU’s foundational CE marking requirements as detai...
In a landscape marked by escalating healthcare expenses and budgetary restrictions, mobile health (m...
The rules outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) ...
Software Medical Devices (or Medical Device Software, as it is generally referred to in the EU), is ...
Conformity assessments for CE approval As indicated on the website of the European Commission, a med...
In the rapidly evolving pharmaceutical industry, computerized systems play a vital role in drug deve...
A comprehensive, objective, and thorough systematic literature review to describe the general State ...
State of the Art (SOTA) literature review is part of the clinical evaluation process of a medical de...
To get and maintain market approval in the EU (CE marking under MDR), state-of-the-art (SOTA) litera...
On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regu...
In June 2022, concerns were expressed that severe challenges related to the implementation of Regula...
Nowadays, regulations on medical devices and medicinal products have very strict expectations on doc...
In order to give patients quicker access to cutting-edge treatments and therapies, the UK government...
The Medicines and Healthcare Products Regulatory Agency ( MHRA) Good Manufacturing and Distribution ...
Annex XVI of the MDR EU 2017/745 lists products (6 categories) without an intended medical purpose t...
Are you performing clinical research with medical devices? In this blog post, we provide a brief ove...
We recently published a blog post about Unique Device Identifiers (UDI). While this blog post briefl...
The European Parliament has adopted the proposal to extend the transitional period for legacy device...
In the world of life sciences, an endless stream of compliance documents is thrown around. It’s no d...
Change control management is an essential part of any quality assurance system. It enables us to mai...
Artificial intelligence (AI) and machine learning (ML) are on the rise in our society, changing the ...
Bringing a Medical Device to market involves many hurdles, including medical device design and medic...
Are you excited to bring your brand-new medical device to market? As you navigate the challenging pr...
ISO, IEC, EN ISO… References to standards can be confusing. What is the difference between these sta...
Any company in the pharmaceutical or medical device industry with a certified GMP, GDP or ISO 13485 ...
Custom-made medical devices are the odd ones out when it comes to the Medical Devices Regulation (EU...
PRRC: meaning of this new role under MDR and IVDR The Person Responsible for Regulatory Compliance o...
A job in life sciences consultancy offers plenty of challenges, variety, career opportunities, and g...
Ever wondered why it is necessary – and sometimes absolutely essential – to perform a Data Migration...
Changes in business needs or technology are inevitable. They often lead to the retirement or “decomm...
Clinical evaluation of a medical device – defined as an ongoing collection, generation, appraisal, a...
Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in ...
During the pandemic, electronic signatures gained tremendous importance for companies in heavily reg...
In vitro diagnostic (IVD) medical devices (Manufacturers | Internal Market, Industry, Entrepreneursh...
In recent years, more and more medicinal products (MP) are used in conjunction with a medical device...
In vitro diagnostic medical devices (IVDs) have long been a part of our healthcare industry. Recentl...
Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)?...
One of our previous blogposts discussed medical device industry trends and innovations. Since then, ...
Artificial Intelligence is the IT word in Medical Devices nowadays when it comes to software develop...
Nowadays, digital healthcare is taking an increasingly important place in the medical world through ...
Needless to say, Brexit has had a major impact on numerous businesses. And that was no different for...
What is a medical device? This crucial question often arises when bringing medical devices to market...
Risk management is key to promoting the safety of medical devices. So it’s with good reason that the...
Ideation and feasibility phase Every medical device invention, from a simple syringe to an advanced ...
The EU Medical Device Regulation 2017/745 (MDR) and EU In Vitro Diagnostic Regulation 2017/746, (IVD...
A short introduction and overview of the requirements In 2017, the European Commission released the ...